MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 TC3 RP TIBIAL INSERT S2,12.5; SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT

Catalog Number	962322
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Discomfort (2330); Not Applicable (3189)
Date of Event	04/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Der states that the patient was experiencing some mild discomfort with her left total knee with depuy tc3/mbt revision style components.The left knee was aspirated and determined not to be infected.The knee was surgically operated and explored.The surgeon determined that none of the components were loose.The polyethelyene tibial insert was removed to attain better surgical exposure and access to the posterior soft tissue.It was determined from trailing that the final tibial insert should be increased from a 12.5mm to 17mm thickness.Doi:unknown dor: (b)(6) 2018, left knee.
Additional Manufacturer Narrative
(b)(4) no device associated with this report was received for examination.If information is obtained that was not available for the initial medwatch , a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: TC3 RP TIBIAL INSERT S2,12.5
• Common Device Name: SIGMA REVISION IMPLANT : KNEE TIBIAL INSERT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic drive; warsaw IN 46582 0988
• MDR Report Key: 7472461
• Report Number: 1818910-2018-58506
• Device Sequence Number: 16175020
• Product Code: NJL
• UDI-Device Identifier: 10603295242055
• UDI-Public: 10603295242055
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P830055
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 962322
• Device Lot Number: 352223
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/03/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 04/30/2018
• Supplement Report FDA Received Date: 07/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR